| 26 Jul 2024 | Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide,… | Device | Class II | 1 | Ongoing |
| 29 Apr 2024 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS | Device | Class I | 3 | Ongoing |
| 12 Feb 2024 | ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l)… | Device | Class I | 1 | Ongoing |
| 10 Aug 2023 | Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter | Device | Class I | 4 | Ongoing |
| 10 Aug 2023 | Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular | Device | Class II | 2 | Ongoing |
| 19 May 2023 | ARROW Endurance Extended Dwell Peripheral Catheter System | Device | Class I | 1 | Ongoing |
| 27 Oct 2022 | Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer | Device | Class I | 2 | Terminated |
| 17 Oct 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump | Device | Class I | 31 | Ongoing |
| 14 Sep 2022 | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. | Device | Class II | 1 | Terminated |
| 5 May 2022 | Arrow Three-Lumen CVC | Device | Class II | 1 | Terminated |
| 20 Sep 2021 | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts | Device | Class I | 4 | Terminated |
| 19 May 2021 | Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording. | Device | Class II | 4 | Ongoing |
| 8 Mar 2021 | Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions. | Device | Class II | 1 | Ongoing |
| 6 Jan 2021 | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A | Device | Class II | 1 | Terminated |
| 6 Jul 2020 | Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space. | Device | Class II | 4 | Terminated |
| 20 May 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | Device | Class I | 10 | Terminated |
| 8 May 2020 | Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for… | Device | Class II | 1 | Ongoing |
| 15 Jan 2020 | FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B | Device | Class II | 49 | Terminated |
| 20 Dec 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Device | Class II | 20 | Terminated |
| 12 Dec 2019 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels. | Device | Class II | 1 | Ongoing |
| 6 Dec 2019 | Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH | Device | Class II | 1 | Terminated |
| 15 Nov 2019 | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 | Device | Class II | 2 | Terminated |
| 6 Aug 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular,… | Device | Class II | 2 | Terminated |
| 18 Jul 2019 | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The… | Device | Class II | 1 | Terminated |
| 17 May 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access | Device | Class II | 1 | Terminated |
| 23 Apr 2019 | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Device | Class II | 36 | Terminated |
| 10 Jan 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132 | Device | Class II | 2 | Terminated |
| 13 Dec 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for… | Device | Class II | 2 | Terminated |
| 14 Nov 2018 | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not… | Device | Class II | 1 | Terminated |
| 2 Oct 2018 | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump | Device | Class II | 17 | Terminated |
| 21 Sep 2018 | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus… | Device | Class II | 1 | Terminated |
| 30 Aug 2018 | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites, Central… | Device | Class II | 1 | Terminated |
| 30 Jul 2018 | ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording | Device | Class II | 1 | Terminated |
| 17 Jul 2018 | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2 | Device | Class II | 2 | Terminated |
| 10 Jul 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer. | Device | Class II | 2 | Terminated |
| 3 Jul 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against… | Device | Class II | 1 | Terminated |
| 23 May 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation. | Device | Class II | 1 | Terminated |
| 17 May 2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is… | Device | Class II | 4 | Terminated |
| 11 May 2018 | Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins. | Device | Class II | 1 | Terminated |
| 11 Apr 2018 | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000 | Device | Class II | 76 | Terminated |
| 22 Dec 2017 | (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A | Device | Class II | 14 | Terminated |
| 21 Dec 2017 | ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections… | Device | Class II | 1 | Terminated |
| 15 Dec 2017 | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B | Device | Class II | 1 | Terminated |
| 27 Nov 2017 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple… | Device | Class II | 12 | Terminated |
| 14 Nov 2017 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation. | Device | Class II | 9 | Terminated |
| 26 Oct 2017 | Radial Artery Catheterization Kit; Model: AK-04018 | Device | Class II | 7 | Terminated |
| 24 Oct 2017 | Large Volume Abdominal Paracentesis Kit | Device | Class II | 3 | Terminated |
| 17 Oct 2017 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet | Device | Class II | 1 | Terminated |
| 17 Oct 2017 | Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018 | Device | Class II | 12 | Terminated |
| 25 Jul 2017 | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter | Device | Class II | 2 | Terminated |
| 10 Jul 2017 | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. | Device | Class II | 1 | Terminated |
| 12 Jun 2017 | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Device | Class II | 2 | Terminated |
| 1 Jun 2017 | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the… | Device | Class II | 4 | Terminated |
| 9 May 2017 | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels | Device | Class II | 12 | Terminated |
| 28 Apr 2017 | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters | Device | Class II | 1 | Terminated |
| 20 Mar 2017 | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter… | Device | Class II | 56 | Terminated |
| 17 Mar 2017 | Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not… | Device | Class II | 1 | Terminated |
| 3 Mar 2017 | The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein. | Device | Class II | 1 | Terminated |
| 11 Jan 2017 | Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. | Device | Class II | 1 | Terminated |
| 2 Sep 2016 | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination. | Device | Class II | 1 | Terminated |
| 8 Aug 2016 | Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels. | Device | Class II | 2 | Terminated |
| 7 Jul 2016 | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli. | Device | Class II | 1 | Terminated |
| 2 Jun 2016 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or… | Device | Class II | 1 | Terminated |
| 2 Jun 2016 | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. | Device | Class II | 2 | Terminated |
| 17 Feb 2016 | Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components | Device | Class II | 4 | Terminated |
| 12 Jan 2016 | Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral… | Device | Class II | 1 | Terminated |
| 16 Oct 2015 | ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous… | Device | Class II | 1 | Terminated |
| 18 Sep 2015 | 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days. | Device | Class II | 1 | Terminated |
| 27 Aug 2015 | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Device | Class II | 1 | Terminated |
| 30 Jul 2015 | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days | Device | Class II | 1 | Terminated |
| 30 Jul 2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound | Device | Class II | 1 | Terminated |
| 5 Feb 2015 | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work… | Device | Class II | 1 | Terminated |
| 9 Jan 2015 | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing | Device | Class III | 1 | Terminated |
| 5 Jan 2015 | ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement. | Device | Class II | 1 | Terminated |
| 2 Jan 2015 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins. | Device | Class II | 1 | Terminated |
| 16 Dec 2014 | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system… | Device | Class II | 1 | Terminated |
| 10 Nov 2014 | Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Device | Class II | 1 | Terminated |
| 18 Sep 2014 | Multi-Lumen Central Venous Catheterization Kit | Device | Class II | 1 | Terminated |
| 15 Sep 2014 | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit | Device | Class II | 1 | Terminated |
| 6 Aug 2014 | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. | Device | Class II | 1 | Terminated |
| 14 Apr 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. | Device | Class II | 1 | Terminated |
| 24 Mar 2014 | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. | Device | Class II | 1 | Terminated |
| 8 Nov 2013 | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS | Device | Class II | 1 | Terminated |
| 9 Oct 2013 | Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Device | Class II | 1 | Terminated |
| 9 Oct 2013 | Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. | Device | Class II | 1 | Terminated |
| 31 Jul 2013 | Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. | Device | Class II | 1 | Terminated |
| 17 Jul 2013 | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. | Device | Class II | 1 | Terminated |
| 17 Jul 2013 | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. | Device | Class II | 1 | Terminated |
| 4 Mar 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to… | Device | Class II | 1 | Terminated |
| 4 Feb 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX,… | Device | Class II | 1 | Terminated |
| 27 Nov 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. | Device | Class II | 2 | Terminated |
| 7 Jun 2012 | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to… | Device | Class II | 1 | Terminated |
| 3 May 2012 | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation. | Device | Class I | 1 | Terminated |